Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Xuzhou Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD22:TCRz:4-1BB chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating recurrent patients with refractory or resistant lymphoma to anti-CD19:TCRz:CD28 CAR-T cells. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Among the many emerging immunotherapeutic approaches, clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. CARs combine the variable region of an antibody with T-cell signaling moieties to confer T-cell activation with the targeting specificity of an antibody. Thus, CARs are not MHC-restricted so they are not vulnerable to MHC down regulation by tumors. However, defined by the recession of evaluable lesions, the persistence and efficacy of CAR-T cells are still restricted by the "target" selection. Previous clinical studies largely utilized CD19 for the in vivo targeting of CAR-T cells, which preferentially become refractory or resistant due to the heterogeneity of lymphoma. This clinical investigation is to test a hypothesis whether anti-CD22 CAR-T cells work more effective in lymphoma patients refractory or resistent to anti-CD19:TCRz:CD28 CAR-T cells.
Primary Objectives
Secondary Objectives
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD22 CAR-T | Experimental | Administrated with CD22.CAR-T cells on day 0,1,2 in the lympho-depleted patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retroviral vector-transduced autologous T cells to express CD22-specific CARs | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | 8 Weeks | |
| Duration of CAR-positive T cells in circulation | 6 months | |
Not provided
Inclusion Criteria:
1.18 Years to 70 Years, Male and female;
2.Expected survival > 12 weeks;
3.Performance score 0-2;
4.Histologically confirmed as CD19-positive lymphoma and who meet one of the following conditions;
Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment;
Disease recurrence after stem cell transplantation;
Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
5.Creatinine < 2.5 mg/dl;
6.ALT/AST < 3x normal;
7.Bilirubin < 2.0 mg/dl;
8.Adequate venous access for apheresis, and no other contraindications for leukapheresis;
9.Take contraceptive measures before recruit to this trial;
10.Written voluntary informed consent is given.
11.Refractory ot resistant to prior anti-CD19 CAR-Ts
12.At least one evaluable CD22-positive recurrent lesion, confirmed by two independent pathologist.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Xinqiao Hospital | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Total number of CAR-positive T cells infiltrated into lymphoma tissue |
| 6 months |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided